Projects
VSGPL has had the privilege of serving many Pharmaceutical/ Biotechnology organizations. We have conducted several trainings in various organizations and academic institutions like USV Ltd. Venkateshwara Hatcheries, Zenith, Biopharmax, GHPL and many others. D. Y. Patil College of Pharmacy, Pune and so on. We have also conducted GMP audits for several clients. Besides we have presented Data Integrity and CSV sessions at ISA meetings. Listed below are a few of our key engagements which show our diverse portfolio:
Anthem Biosciences Pvt Ltd, Bengaluru
VSGPL successfully completed detail engineering and qualification services (including control systems like PCS and BMS) for Anthem’s Biological API project at Harohalli, Bengaluru.
Biocon SDN, Malaysia
VSGPL completed document designing services for Biocon (SDN) in Malaysia, where systems were being updated as well as upgraded for compliance and standard practices. In addition to that we also created GMP (ALCOA+) videos for Biocon to display throughout their Malaysia facility.
Biocon Biologics, Biocon Biosphere, Biocon Ltd, Hyderabad, Bengaluru and Visakhapatnam
VSGPL has successfully completed CSV projects for BBL in Bengaluru and provided services to the Biocon plant in Vizag, where systems like the pinch-coil were being commissioned, in Hyderabad for computer systems validation of the plant control system and Bengaluru for the new Injectable facility.
USV Pvt. Ltd, Mumbai
VSGPL has provided several training sessions on Quality and Regulatory at the USV Corporate Headquarters in Govandi, Mumbai. Additionally, VSGPL has also performed validation of our eLMS software deployed across USV.
DoveTail Systems, LLC, Netherlands
VSGPL provided concept design services for vaccine projects in Europe and Asia
Biopharmax India Pvt. Ltd, Pune
Biopharmax is an EPC organization providing design & construction services for manufacturing facilities. Together with Biopharmax, VSG has handled some high-profile qualification and validation projects for major companies in India like Abbott India Ltd., Akorn Ltd and Wockhardt Ltd.
Currently VSGPL along with Biopharmax is working on validation of Craftsman automated storage and retrieval system (ASRS) at Granules India Ltd, Hyderabad.
Integrated Clean Room Technologies, Hyderabad
VSGPL Supported iClean in their project at the Disease Investigation Section, Govt of Maharashtra, Pune. VSGPL evaluated, identified procured and qualified laboratory systems and instruments for their Animal Disease Investigation Laboratory.
Novartis Healthcare Pvt Ltd, Hyderabad
VSGPL is assisting Novartis for asset lifecycle management project which includes Instrument and Equipment Inventory Management, Maintenance and Calibration plans and Master Data preparation for Process, EMS and Utilities equipment in CMMS.
Syngene international Limited, Bengaluru
VSGPL validated the Perkin Elmer E-notebooks at Syngene which included document preparation execution and reporting.
Accely, Mumbai
VSGPL successfully completed validation of SAP S/4 HANA for Kuwait Saudi Pharmaceutical
Cipla, Bengaluru
VSGPL successfully completed Utility Reviews and P&ID preparations along with review of work breakdown structure at Cipla.
Flamingo Pharmaceuticals, Nanded
VSGPL completed Gap-Analysis of computerized systems at the Flamingo plant in Nanded and proposed mitigations for the firm to comply with their customer and regulatory requirements as far as data integrity is concerned.
Enzene Biosciences Ltd, Pune
VSGPL successfully completed several projects for 2 units of Enzene Biosciences Ltd these include facility Gap Assessments and remediation, Risk Assessments for Contamination Control, Excel / Spreadsheet Validation, QC and QA data review, Investigation support and SOP preparation for their US facility.
Emmersive Infotech, India and US
Along with Emmersive, VSGPL successfully executed few projects key being training modules preparation for Biotech Primer, USA in the area of Biosafety, GMP and Data Integrity, Regulatory Aspects of small molecules, CAR-T Cell therapy.
Dr. Reddy’s Laboratories, Hyderabad and Bengaluru
VSGPL is providing continued CSV support to DRL by deploying skilled and trained resources on their key projects in Hyderabad and Bengaluru. The resources achieved a successful milestone in audit preparation, timely documentation for the new facilities and areas.
Emerson Export Engineering, Pune
VSGPL has supported Emerson in their automation projects for the life sciences industry. Our staff has single handedly taken on CSV for Delta-V systems at several clients of Emerson such as MSD, Pfizer, Astra Zeneca and so on.
Ventri Biologicals Pvt. Ltd., Pune
Ventri Biologicals is a WHO approved poultry vaccine manufacturer. VSGPL provided Quality Control systems services to Ventri Biologicals and helped with specifications, vendor qualifications etc. An ongoing project at Ventri is CSV of their Manufacturing systems to meet their commitment for EU Approvals.
Divi’s Laboratories, Hyderabad
VSGPL successfully completed commissioning and qualification of the continuous granulation suite at Divi’s Laboratories Limited at their site in Visakhapatnam.
Steer Life India Pvt. Ltd., Bengaluru
VSGPL successfully completed designing qualification protocols Steers Hot Melt Extruder (HME) projects at Acebright China, DRL China and Emcure Pharmaceuticals Pvt. Ltd. Pune.
IDMC, Anand
Along with Propharm Engineering, VSGPL served as a consultant for design and review of the Commissioning, Qualification planning and documentation to IDMC for their Project at Biocon, Visakhapatnam.
Antero Engineering, Singapore
Antero Engineering is based in Singapore. VSGPL supported Antero in detail engineering, technology transfer, qualification and validation services and QMS documentation for a vaccine manufacturing company – Biondvax Pharmaceuticals in Israel. VSGPL also assisted Hilleman Laboratories of Singapore for commissioning and qualification of their facility for manufacturing of Clinical Phase I and Phase II Vaccines and Biologicals. Additionally, with Antero we have also provided QMS documentation and IT services for a Single Use Systems – medical device manufacturer, AranBio in Israel.
Currently VSGPL is providing document preparation and review services to Scinai Immunotherapeutics Ltd. Israel
Cognizant, India
VSGPL has successfully completed Laboratory Systems CSV projects at Pfizer, Aurangabad and worked with the Zenith Team on the CSV of Manufacturing Systems, Emcure Pharmaceuticals, Pune, Tmunity USA and Ipsen, France. Also, along with Zenith our resources are currently working with organizations such as Dr. Reddy’s, Hyderabad, Viatris Aurangabad, Indore and Nasik. Currently the VSGPL team is supporting CTS in Automation design and development for their lifescience clients in India as well as overseas.
L&T Technology Services (LTTS) Japan
VSGPL along with LTTS is currently providing Engineering Services for the Equipment Readiness and Production start-up/ testing activities related to process equipment at Shimotsuma Site in Japan for their client – the cosmetic giant Estée Lauder Companies (ELC). Services include process engineering, cGMP consulting services, commissioning & qualification, Computer System Validation and QMS services to achieve successful production start-up.
Granules, India
Granules India has partnered with Vita Scientia Globus Pvt Ltd (VSGPL) for comprehensive CSV activities covering Manufacturing Execution System (MES) validation and Level 2 integration.